Prostate Screening Study Using MRI in BRCA Carriers

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: MS3TMRI / TRUS Guided Biopsy

• Registration Number: NCT01990521
• Lead Sponsor: Toronto Sunnybrook Regional Cancer Centre

Brief Summary

Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate cancer compared to men in the general population.

Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination (DRE), the same as with men in the general population.

This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease.

Detailed Description

To determine the value of using Multispectral 3T MRI (MS3TMRI) for prostate cancer screening in men with a high risk of developing early onset aggressive prostate cancer given known BRCA1 or BRCA2 mutation carrier status, with no prior prostate cancer diagnosis, independent of baseline PSA levels.

* Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels.

* To evaluate the accuracy of tumor targeting based on MRI and ultrasound (US) tumor co-localization. To evaluate the sensitivity, specificity, PPV, NPV, and accuracy of an automated computer aided diagnosis method (CAD) applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant cancer.

Study Timeline

• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-21
• Study Start: 2014-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center.
• Have positive genetic testing for a pathogenic BRCA1 or BRCA2 mutation.
• Clinically eligible for and willing to undergo ultrasound biopsy within 4 weeks after the MRI.
• Be 50 years of age or older.

Exclusion Criteria

• Claustrophobia
• Contraindication to MRI
• Contraindication to receiving low molecular weight MRI contrast agent
• Previously diagnosed with prostate cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MS3TMRI / TRUS Guided Biopsy	MS3TMRI / TRUS Guided Biopsy	-

Primary Outcome Measures

Name	Time	Method
Prostate MRI in BRCA carriers	2 years (January 2016)	Measure of prostate MRI to determine the PPV of MRI for detection of actionable prostate cancer

Secondary Outcome Measures

Name	Time	Method
Prostate cancer in BRCA carriers	2 years January 2016	Prevalence of any prostate cancer compared to actionable cancer in men with a BRCA1 or BRCA2 mutation independent of serum PSA value.

Trial Locations

Locations (1)

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada